Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial.

Autor:	Deer TR; Center for Pain Relief, Charleston, WV, USA., Levy RM; Marcus Neuroscience Institute, Boca Raton, FL, USA., Kramer J; St. Jude Medical, Sunnyvale, CA and Plano, TX, USA., Poree L; University of California, San Francisco, San Francisco, CA, USA., Amirdelfan K; IPM Medical Group, Inc, Walnut Creek, CA, USA., Grigsby E; Neurovations, Napa, CA, USA., Staats P; Premier Pain Center, Shrewsbury Township, NJ, USA., Burton AW; Houston Pain Centers, Houston, TX, USA., Burgher AH; HOPE Research-TPC, Phoenix, AZ, USA., Obray J; HOPE Research-LVSP, Las Vegas, NV, USA., Scowcroft J; Pain Management Associates, Independence, MO, USA., Golovac S; Florida Pain, Merritt Island, FL, USA., Kapural L; Carolinas Pain Institute, Winston-Salem, NC, USA., Paicius R; Newport Beach Headache and Pain, Newport Beach, CA, USA., Kim C; Center for Pain Relief, Charleston, WV, USA., Pope J; Center for Pain Relief, Charleston, WV, USA., Yearwood T; Comprehensive Pain and Rehabilitation, Pascagoula, MS, USA., Samuel S; Cleveland Clinic, Cleveland, OH, USA., McRoberts WP; Holy Cross Hospital, Ft. Lauderdale, FL, USA., Cassim H; Eisenhower Medical Center, Rancho Mirage, CA, USA., Netherton M; Southeastern Spine Institute, Mt. Pleasant, SC, USA., Miller N; Coastal Pain Research, Carlsbad, CA, USA., Schaufele M; Drug Studies America, Marietta, GA, USA., Tavel E; Clinical Trials of South Carolina, Charleston, SC, USA., Davis T; Orthopaedic Pain Specialists, Santa Monica, CA, USA., Davis K; St. Jude Medical, Sunnyvale, CA and Plano, TX, USA., Johnson L; St. Jude Medical, Sunnyvale, CA and Plano, TX, USA., Mekhail N; Cleveland Clinic, Cleveland, OH, USA.
Jazyk:	angličtina
Zdroj:	Pain [Pain] 2017 Apr; Vol. 158 (4), pp. 669-681.
DOI:	10.1097/j.pain.0000000000000814
Abstrakt:	Animal and human studies indicate that electrical stimulation of dorsal root ganglion (DRG) neurons may modulate neuropathic pain signals. ACCURATE, a pivotal, prospective, multicenter, randomized comparative effectiveness trial, was conducted in 152 subjects diagnosed with complex regional pain syndrome or causalgia in the lower extremities. Subjects received neurostimulation of the DRG or dorsal column (spinal cord stimulation, SCS). The primary end point was a composite of safety and efficacy at 3 months, and subjects were assessed through 12 months for long-term outcomes and adverse events. The predefined primary composite end point of treatment success was met for subjects with a permanent implant who reported 50% or greater decrease in visual analog scale score from preimplant baseline and who did not report any stimulation-related neurological deficits. No subjects reported stimulation-related neurological deficits. The percentage of subjects receiving ≥50% pain relief and treatment success was greater in the DRG arm (81.2%) than in the SCS arm (55.7%, P < 0.001) at 3 months. Device-related and serious adverse events were not different between the 2 groups. Dorsal root ganglion stimulation also demonstrated greater improvements in quality of life and psychological disposition. Finally, subjects using DRG stimulation reported less postural variation in paresthesia (P < 0.001) and reduced extraneous stimulation in nonpainful areas (P = 0.014), indicating DRG stimulation provided more targeted therapy to painful parts of the lower extremities. As the largest prospective, randomized comparative effectiveness trial to date, the results show that DRG stimulation provided a higher rate of treatment success with less postural variation in paresthesia intensity compared to SCS.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu